BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2939653-2018-00010

    MDR report key: 7597565 · Received June 13, 2018

    Report

    Report Number
    2939653-2018-00010
    Event Type
    Injury
    Date Received
    June 13, 2018
    Date of Event
    May 24, 2018
    PMA / PMN Number
    K162416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PER PHYSICIAN: "PATIENT WAS UNDER GENERAL ANESTHESIA FOR A COMBO CASE OF AHMED VALVE REMOVAL AND CYCLOPHOTOCOAGULATION (CPC). VALVE REMOVAL WAS DONE FIRST AND THE CPC FOLLOWED. THE PHYSICIAN USED THE CROSS ILLUMINATION TECHNIQUE AND MARKED ANTERIOR OF THE CILIARY BODY WITH A GENTIAN VIOLET SKIN MARKER. THE FIRST APPLICATION OF THE CPC RESULTED IN A SCLERAL BURN. ADDITIONAL SHOTS DID NOT RESULT IN BURNS AS HE MOVED THE PROBE AWAY FROM INK MARKS ON THE EYE. SINCE THE VALVE REMOVAL WAS DONE PRIOR TO THE CPC PROCEDURE THERE WAS ALSO BLOOD ON THE SURFACE OF THE EYE THAT HAD TO CONTINUALLY BE RINSED OFF DURING THE PROCEDURE." IRIDEX BELIEVES THE PRESENCE OF THE GENTIAN VIOLET MARKER AND EXCESS BLOOD MAY BE CONTRIBUTING FACTORS TO THE SCLERAL BURN.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other